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临床试验/NCT04663412
NCT04663412Unknown不适用

Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer: Peritumoral Injection Dosage and Waiting Times in Our Experience

Azienda Ospedaliera per l'Emergenza Canizzaro1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
2
试验地点
1
主要终点
Progression-free survival

研究概览

简要总结

The potential of the administration of indocyanine green (ICG) allows the execution of SLN biopsy, avoiding the multiple administrations of radiocolloid in the pre-operative phase, painful for the patient, elimination, and exposure to radioactivity. Therefore, while requiring standardization of the methodology and a large-scale application, this procedure could open a new surgical management perspective in patients with early-stage vulvar cancer.

详细描述

According to The European Society of Gynaecological Oncology (ESGO) guidelines, the investigators decided to treat patients with vulvar squamous cell carcinoma (vSCC), FIGO stage IB with radical vulvectomy, sentinel lymph node search, and removal with indocyanine green (ICG) subsequent bilateral inguinofemoral lymphadenectomy.

Intraoperative imaging system The SPY Portable Handheld Imager (SPY-PHI) © Stryker was used as the intraoperative imaging device. This device uses SPY fluorescence imaging technology to visually assess blood circulation in blood vessels and associated tissue perfusion during surgery. The design of SPY-PHI makes the device versatile, enabling the operator to frame the operating field and use the acquired images in real-time, integrating fluorescence signal data with white light images in real-time. The SPY Portable Handheld Imaging System Camera, with integrated optics and cables for real-time fluorescence imaging in visible light and near-infrared, is ideal for open surgery.

Intraoperative detection of the sentinel lymph node The fluorescent agent was administered to patients placed in the lithotomy position under general anesthesia. Indocyanine green (ICG) prepared with a 25 mg vial of green indocyanine green (ICG) (Pulsion Medical Systems AG, Munich, Germany) diluted in 50 mL of water for injections (B. Braun Medical) was used, resulting in a concentration of 0.5 mg/mL. Injection of 1 ml per quadrant was administered in the three quadrants around the vulvar lesion. After the injection, the infrared camera, equipped with a movable arm, was placed in front of the patient to detect transcutaneous fluorescence during surgery. Subsequently, the SLN was localized based on the fluorescence intensity. The intraoperative fluorescence detection camera system was used to open, identify, and remove the SLN and the vulvectomy of the groin. After the excision, the capture of the residual lymphatic pathway could be seen bilaterally through the infrared camera. Additionally, all SLNs were subject to ex vivo imaging due to the presence of fluorescence. The excised SLNs were sent to pathological anatomy and processed according to the standard SLN protocol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients diagnosed with vulvar squamous cell carcinoma FIGO IB stage

排除标准

  • 未提供

研究组 & 干预措施

Patients FIGO IB stage

Experimental

Vulvar Cancer IB stage

干预措施: Sentinel lymph node mapping with indocyanine green fluorescence imaging in vulvar cancer (FIGO Stage IB) (Other)

结局指标

主要结局

Progression-free survival

时间窗: 3 years

The length of time during and after the treatment of vulvar cancer with sentinel node, that a patient lives with the disease but it does not get worse.

次要结局

  • Overall Survival(3 years)

研究者

发起方
Azienda Ospedaliera per l'Emergenza Canizzaro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Scollo

Professor

Azienda Ospedaliera per l'Emergenza Canizzaro

研究点 (1)

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